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The Solvo 35W is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo 35W is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy
• Urology
• Lithotripsy
• Pulmonology
• Gastroenterology
• Gynecology
• ENT
• General Surgery

The Dornier Medilas H Solvo 35 Laser is a solid-state Holmium YAG Laser. The laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400 um (0.4mm). Due to the application-dependent optimization of the pulse time of 350 microseconds, the Solvo can be used in various medical applications including breaking up stones, cutting tissue, tissue ablation, coaqulation and vaporization.

The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. The bottom of the housing serves as a tank for cooling water and, at the same time, a base for the laser unit. A cooling circuit conducts away heat that is generated by the laser pump lamp. Water heated by the laser pump is conducted out of the cavity and into the stainless steel cooler. Following cooling, it is returned to the tanks.

A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the user. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser. There is a wireless remote display panel available as well that allows the user to see the control panel information without being in front of the unit.

The provided document is a 510(k) premarket notification summary for a medical device, the Dornier Medilas H Solvo 35 Laser. It describes the device, its intended use, technological characteristics, and its substantial equivalence to a predicate device.

Key takeaway regarding Acceptance Criteria and Study proving device meets criteria:

Based on the provided text, there is no specific clinical study with human patients described that establishes acceptance criteria for performance metrics like accuracy, sensitivity, or specificity for a diagnostic or AI-driven device. This document is for a surgical laser, a therapeutic device, and the evaluation for substantial equivalence primarily focuses on engineering specifications, safety standards, and technological characteristics compared to a previously cleared predicate device.

Therefore, many of the requested points regarding sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable or not mentioned in this type of submission for this particular device.

Here's how to address your request based on the information available:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for this type of device and submission. This 510(k) is based on engineering verification and validation testing, compliance with standards, and comparison to a predicate device, not a clinical study on a patient test set to evaluate diagnostic performance. The "performance data" section refers to adherence to voluntary standards and software V&V, not clinical outcomes data from a specific patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No clinical ground truth was established by experts for a test set in this submission. The "truth" for this device is its adherence to specified engineering parameters and safety standards, verified through bench testing and documentation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring expert adjudication was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a surgical laser, not an AI-driven diagnostic or assistive technology. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a hardware surgical device, not an algorithm. Benchtop testing and engineering verification ensure its standalone performance against specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this submission revolves around engineering specifications, compliance with recognized voluntary standards (e.g., IEC standards for medical electrical equipment and laser safety), and risk management (ISO 14971). For software, software verification and validation serve as the "ground truth" that the software performs as intended. The "truth" is that the device, when manufactured and used correctly, is safe and effective within its specified parameters and is substantially equivalent to the predicate.

8. The sample size for the training set

• Not applicable. This is a hardware device submission, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set for an AI model.

In summary, the provided document is a regulatory submission for a medical device that is a surgical laser. The "acceptance criteria" and "study" described are primarily related to engineering validation, compliance with established safety and performance standards for medical electrical equipment and lasers, and demonstration of substantial equivalence to a legally marketed predicate device. It does not involve typical clinical study designs for diagnostic devices or AI algorithms that would require patient data, expert ground truth, or statistical performance metrics like sensitivity/specificity.

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